MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX 15 HOLLOW FIBER OXYGENATOR

Catalog Number CX*FX15RW30

Device Problem Increase in Pressure (1491)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 11/18/2014

Event Type  Injury  

Event Description

The user facility reported pressure increase during bypass surgery.Follow up information from the user facility reported the following: (1) after thirty three minutes of perfusion the oxy-pressure increased from 380 to 460 mmhg; (2) fibrindeposite were visible on the oxy; (3) the complete machine was replaced with a maquet system; (4) blood loss was estimated at 600ml due to machine chance out; (5) the surgery was successful completed; (6) a ct scan was done on the patient which confirmed absence of any negative effects; and (7) there was no harm to the patient.

Manufacturer Narrative

(b)(4).- although there were reportedly no impact to the patient, the event description indicates an estimated amount of volume of blood loss was 600ml.The actual device was returned to the manufacturing facility and evaluated.Visual inspection of the actual sample upon receipt found the formation of thrombus on the surface of the filter.The actual sample was rinsed, dried and built into a circuit with tubes, where bovine blood was filled and then circulated at each flow rate to determine the pressure drop.The obtained values were verified to be within the specifications.The bovine blood was kept circulated in the circuit for 6 hours, no anomaly was noted.The pump record from the involved procedure was reviewed.An increase in the pressure and a decrease in the temperature were noted.A review of the blood date did not find any anomaly which could definitely relate to the increase in the pressure.A review of the manufacturing record and product release decision control sheet of the involved product/lot# combination confirmed there were no indications of production-related anomalies.A search of the complaint file found no other similar complaint with the involved product/lot# combination.Based upon the available information, the cause for the reported event cannot be definitively determined.There are many complex clinical variables that may have affected the reportedly observed conditions during the procedure.However, there is no indication that the reported event was related to a product malfunction or defect.All currently available information has been placed on file by qa at the manufacturing facility for appropriate tracking, trending, and follow up.(b)(4).

• Brand Name: CAPIOX FX 15 HOLLOW FIBER OXYGENATOR
• Type of Device: OXYGENATOR
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: cathleen hargreaves ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 4342734
• MDR Text Key: 18919488
• Report Number: 9681834-2014-00322
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/25/2014,12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CX*FX15RW30
• Device Lot Number: 131022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2014
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/18/2014
• Event Location: Hospital
• Date Report to Manufacturer: 11/25/2014
• Date Manufacturer Received: 11/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR